Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utilized on all upright ZEISS microscopes (Axio I

FDA device recall Z-0799-2014 · posted 2014-01-21 · Terminated

Recall details

Recalling firm

Zeiss, Carl Inc

Reason for recall

Carl Zeiss Microscopy, LLC has recalled the Compensator Slider Lamda 6x20 component utilized on Standard Pathology Microscopes due to misalignment of the lambda plate.

Action taken

Carl Zeiss, Inc. sent an Important Medical Device Corrective Action letter dated December 20, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised that their service provider would contact them to schedule a visit in which a factory trained service technician would install a new Compensator Slider Lambida 6x20. Customers should return the old Compensator Slider to the factory for testing. Customers with technical questions were instructed to call 914-681-7815.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

IBJ

Quantity affected

335 units Total (14 domestically & 321 internationally)

Distribution

Worldwide Distribution - Nationwide including NY, TX, NC, FL, ME, MA and MI; and Internationally to Arab Emirates, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Egypt

Date initiated

2013-12-20

Date posted

2014-01-21

Date terminated

2015-04-08

Location

Thornwood, NY